Letter 10 October: FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders

1w
5m read
Summary

When considering use of compounded ketamine products, patients and health care providers should know: Ketamine is not FDA approved for the treatment of any psychiatric disorder. Compounded drugs, including compounded ketamine products, are not FDA approved, which means FDA has not evaluated their safety, effectiveness, or quality prior to marketing. In fact, because compounded ketamine products are not subject to monitoring requirements under a REMS, they may be less safe. Home use of compounded ketamine products presents additional risk because onsite monitoring by a health care provider is not available. In addition to the potential risks associated with compounded ketamine products, patients and health care providers should be aware that information about use of these products is lacking.

Article Preview

This is what the FDA has just sent out

October 10, 2023

What Patients and Health Care Providers Should Know

There is increased interest in compounded ketamine products (including oral formulations) for the treatment of psychiatric disorders. When considering use of compounded ketamine products, patients and health care providers should know:

Ketamine is not FDA approved for the treatment of any psychiatric disorder. FDA is aware that compounded ketamine products have been marketed for a wide variety of psychiatric disorders (e.g., depression, anxiety, post-traumatic stress disorder (PTSD), and obsessive-compulsive...

Read the full article @ Cannabis Law Report